Events

Retiro De Equipo (Recall) de ANIMAS 2020 INSULIN INFUSION PUMP (WARRANTY REPLACEMENT VARIOUS COLOURS)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ANIMAS CORPORATION.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    32641
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-12-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A small number of animas 2020 insulin infusion pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. this component misalignment results in the insulin pump potentially measuring force conditions incorrectly resulting in false warnings and/or alarms. should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. there is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump changing the cartridge and rewinding the motor.

Device

ANIMAS 2020 INSULIN INFUSION PUMP (WARRANTY REPLACEMENT VARIOUS COLOURS)
  • Modelo / Serial
    Model Catalog: 100-384-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-385-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-380-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-381-51 (Lot serial: > 100 numbers contact mfg); Model Catalog: 100-382-51 (Lot serial: > 100 numbers contact mfg)
  • Descripción del producto
    Animas 2020 Insulin Infusion Pump
  • Manufacturer
    ANIMAS CORPORATION

Manufacturer

ANIMAS CORPORATION
  • Dirección del fabricante
    WEST CHESTER
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC